MAUDE Adverse Event Report: MSD DEGGENDORF MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4922250
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: degenerative scoliosis procedure: l1-5 anteroposterior fusion.L1-5 oblique lumbar interbody fusion (olif), performed pps on posterior side.Level implanted: l1-5 intraoperative bleeding volume: 3300cc in total (2500cc during olif, 800cc during pps) it was reported that intra-op, after placing the cage at l4/5, the cage proceeded to the contralateral side.It was confirmed by the frontal image by intraoperative c arm that 3/4 of the cage protruded to the contralateral side.Cage was tried to be removed from the invading side, but it did not move at all.At this time, the blood pressure dropped noticeably and removal from the invading side was given up.Because risks such as bleeding were also considered, so the wound was closed and confirmed by ct.The overall operation time was delayed about two and a half hours.Additional surgery was performed by changing the patients positions from the contralateral side and since there was no problem in the cage itself, the cage was implanted into the patient as it was.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 8224514
• Report Number: 1030489-2019-00015
• Device Sequence Number: 18898195
• Product Code: MAX
• UDI-Device Identifier: 00643169191327
• UDI-Public: 00643169191327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2024
• Device Catalogue Number: 4922250
• Device Lot Number: 22CU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR